BREEZE® APD

Basic Information

• Brand Name: BREEZE® APD
• Primary DI: 00884908138641
• Version / Model: BALPN0830S
• Catalog Number: BALPN0830S
• Company Name: Medical Components, Inc.
• Labeler DUNS: 038000253
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-02-26
• Public Version: 1
• Public Version Date: 2022-03-07
• Public Version Status: New
• Public Device Record Key: b1d6696c-aafa-45dc-92e2-370f3d260236

Device Description

8F X 30CM BREEZE® ALL PURPOSE DRAIN WITH LOCKING PIGTAIL SET

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FGE	Stents, drains and dilators for the biliary ducts	Gastroenterology, Urology	876.5010	2

GMDN Terms

Code	Name	Definition	Implantable	Status
32337	Abdominal paracentesis needle, single-use	A sterile, sharp bevel-edged, hollow tubular metal instrument used to perform therapeutic or diagnostic aspiration of fluids/air from the abdominal cavity. It may be used for the placement/operation of a paracentesis catheter or used directly without a catheter. It is typically made of high-grade stainless steel and may have an attached stopcock to control the aspiration process. The device is commonly used to remove ascites fluid from the peritoneal cavity. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	50884908138646	GS1	box	20	In Commercial Distribution
Package	30884908138642	GS1	inner box	5	In Commercial Distribution
Primary	00884908138641	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]